EMA/CHMP back approval of Empliciti for multiple myeloma

The European Medicines Agency has recommended granting a marketing authorization for Empliciti (elotuzumab) for the treatment of multiple myeloma. It is to be used in combination with Revlimid (lenalidomide) and the anti-inflammatory medicine dexamethasone for the treatment of patients who have received at least one prior therapy.

Under development by US pharma majors Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE: ABBV), Empliciti is a monoclonal antibody that works by activating the body’s immune system to attack and kill multiple myeloma cells. The drug received approval last November in the USA, where it carries a cost tag of $10,000 per month, less than current market leader Celgene’s Revlimid which is priced at $14,000 per month. B-MS is solely responsible for commercial activities.

Multiple myeloma is generally an incurable disease that leads to bone destruction and kidney failure. In 2012, around 39,000 people had multiple myeloma in the European Union. Only half of patients diagnosed with multiple myeloma are still alive after five years under currently available treatment. Therefore new medicines are needed for patients whose disease returns after treatment.